(27 days)
Not Found
No
The summary describes a mechanical implant (rods and screws) and explicitly states that mentions of image processing, AI, DNN, or ML were "Not Found". Performance studies and key metrics related to algorithmic performance are also listed as "Not Applicable".
No.
The device is used to stabilize fractures and osteotomies in bones, which is a structural and supportive function, not a therapeutic one that treats or cures a disease.
No
The device description indicates it is an "intramedullary rod with solid and cannulated versions" used for "fractures and osteotomies," which are treatments, not diagnostic processes. Furthermore, there is no mention of image processing, AI, or any diagnostic capabilities.
No
The device description clearly states it includes physical components like rods and screws, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fractures and osteotomies of the radius, ulna, and fibula." This describes a surgical implant used to stabilize bones, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details an "intramedullary rod with solid and cannulated versions" and "cortical screws." This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information based on those measurements
The device described is a surgical implant used in orthopedic procedures.
N/A
Intended Use / Indications for Use
The Acumed Small Bone Locking Rod System II is indicated for use in fractures and osteotomies of the fibula, radius, and ulna.
The Acumed Small Bone Locking Rod System II includes rods and screws, with accessories, for indicated use for fractures and osteotomies of the radius, ulna, and fibula.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Acumed Small Bone Locking Rod II is an intramedullary rod with solid and cannulated versions. Rods are manufactured in multiple lengths (110 mm to 270mm) and diameters (3.0 to 4.5 mm). The rod has openings used in conjunction with cortical screws, which lock it in place.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fibula, radius, ulna
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
AUG - 9 2007
5885 N.W. Cornelius Pass Road, Hillsboro, Oregon 97124-9432
Tel (503) 627-9957
510(k) Summary
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter Information: | Acumed LLC |
|---|---|
| 5885 N.W. Cornelius Pass Road | |
| Hillsboro, OR 97124-9432 | |
| USA | |
| Phone: | (503) 627-9957 |
| FAX: | (503) 686-7102 |
| Contact: | Ed Boehmer, Regulatory Compliance Officer |
| Classification Name: | Rod, Fixation, Intramedullary and Accessorie |
| Classification Name: | Rod, Fixation, Intramedullary and Accessories |
| Common Name: | Radius, Ulna, and Fibula Rods |
| Proprietary Name: | Acumed Small Bone Locking Rod System II |
| Proposed Regulatory Class: | Class II, 21 CFR 888.3020 |
| Device Product Code: | HSB |
| Legally Marketed Equivalent Device(s): | Acumed Small Bone Locking Rod System II K031438 |
Device Description: The Acumed Small Bone Locking Rod II is an intramedullary rod with solid and cannulated versions. Rods are manufactured in multiple lengths (110 mm to 270mm) and diameters (3.0 to 4.5 mm). The rod has openings used in conjunction with cortical screws, which lock it in place.
Intended Use: The Acumed Small Bone Locking Rod II System is indicated for use in fractures and osteotomies of the fibula, radius, and ulna. These are similar to intended use of predicate devices and do not raise new issues of safety and effectiveness.
Technological Characteristics: The Acumed Small Bone Locking Rods II are slightly bowed rods made from titanium alloy in conformance with ASTM F136 and stainless steel ASTM F138 and ASTM F2229. Both titanium alloy and stainless steel have been successfully used in numerous intramedullary rods. There are no technological characteristics that raise new issues of safety or effectiveness.
An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.
Based upon the similarities of the Acumed Small Bone Rod II System and the predicate devices studied, the safety and effectiveness of the Acumed Small Bone Rod II System is substantially equivalent to the predicate devices referenced.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with three overlapping profiles, suggesting community and support. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 9 2007
Acumed, LLC % Mr. Ed Boehmer 5885 NW Cornelius Pass Road Hillsboro, OR 97124
TO, OR 97121
Re: K071944 Trade/Device Name: Acumed Small Bone Locking Rod System II Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: July 11, 2007 Received: July 13, 2007
Dear Mr. Boehmer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Ed Boehmer
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Brown
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
510(k) Number (if known): 长ഗ기 | ٩ ԿՎ
Acumed Small Bone Locking Rod System II Device Name:
Indications For Use:
The Acumed Small Bone Locking Rod System II includes rods and screws, with accessories, for indicated use for fractures and osteotomies of the radius, ulna, and fibula.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dalbare BuehND
(Division Sign Off)
l, Restorative, and Neurological Devices
510(k) Number K071944
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